Neurosoft TMS— 510(k) K160309

Substantially Equivalent

Teleemg, LLC

FDA 510(k) clearance K160309 for Neurosoft TMS, Substantially Equivalent on 2016-12-22. Applicant: Teleemg, LLC.

Clearance details

Applicant: Teleemg, LLC
Product code: Code OBP
Advisory panel: Neurology
Date received: 2016-02-04
Decision date: 2016-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.